BEUDAMED
    FDA Adverse Event Death Summary report: N

    FIXODENT ADHESIVE CREAM, VERSION UNKNOWN

    MDR report key: 22740638 · Received August 7, 2025

    Report

    Report Number
    1530449-2025-00001
    Event Type
    Death
    Date Received
    August 7, 2025
    Date of Event
    June 23, 2024
    Report Date
    August 7, 2025
    Manufacturer
    PROCTER & GAMBLE MANUFACTURING CO.
    Product Code
    KOO
    PMA / PMN Number
    K945200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS INSUFFICIENT INFORMATION TO PERFORM AN INVESTIGATION.

    Description of Event or Problem · 0

    HYPOXIC BRAIN INJURY [BRAIN HYPOXIA], BLOCKED, EXTENDED INTO LEFT BRONCHUS - FIXODENT [BRONCHIAL OBSTRUCTION], THICK ADHESIVE GEL INSIDE MOUTH [FOREIGN BODY IN MOUTH], THICK ADHESIVE GEL INSIDE PHARYNX [FOREIGN BODY IN THROAT], BLOCKED LARYNX - FIXODENT [LARYNGEAL OBSTRUCTION], BLOCKED TRACHEA - FIXODENT [TRACHEAL OBSTRUCTION], UPPER AIRWAY OBSTRUCTION BY THICK ADHESIVE GEL [UPPER AIRWAY OBSTRUCTION], CHOKING [CHOKING], DENTURE ADHESIVE IN EAR [EXPOSURE VIA DIRECT CONTACT], ADULT WITH DEMENTIA FOUND WITH DENTURE ADHESIVE IN MOUTH, (EARS AND NOSE) [ACCIDENTAL DEVICE INGESTION], ADULT WITH DEMENTIA FOUND WITH DENTURE ADHESIVE IN (MOUTH), EARS AND NOSE [ACCIDENTAL EXPOSURE TO PRODUCT BY ELDERLY PERSON], DENTURE ADHESIVE IN MOUTH [EXPOSURE VIA INGESTION], INHALATION OF ADHESIVE GEL - FIXODENT [EXPOSURE VIA INHALATION], BREATHING LABORED [DYSPNOEA], DENTURE ADHESIVE GEL IN EARS [FOREIGN BODY IN EAR], THICK ADHESIVE GEL INSIDE PHARYNX, COMPLETELY BLOCKED LARYNX AND TRACHEA, EXTENDED INTO LEFT BRONCHUS [FOREIGN BODY IN RESPIRATORY TRACT], DENTURE ADHESIVE GEL IN MOUTH, NOSE LARYNX, TRACHEA, BRONCHUS PHARYNX [EXPOSURE VIA MUCOSA], DENTURE ADHESIVE GEL IN NOSE AND EARS [WRONG TECHNIQUE IN DEVICE USAGE PROCESS]. CASE NARRATIVE: A CORONER REPORTED VIA EMAIL ON 27-FEB-2025 THAT A (B)(6)-YEAR-OLD MALE PATIENT WITH DEMENTIA (DIAGNOSED ON (B)(6) 2022) THAT LIVED IN A CARE HOME WAS FOUND BY A MEMBER OF STAFF ON (B)(6) 2024 WITH FIXODENT DENTURE CARE DENTURE ADHESIVE IN HIS MOUTH, EARS, AND NOSE. UNSPECIFIED ATTEMPTS WERE MADE TO REMOVE THE SUBSTANCE FROM HIS MOUTH. HIS BREATHING BECAME LABORED (BEGINNING ON (B)(6) 2024). PARAMEDICS ATTENDED TO HIM AND TRIED TO REMOVE THE GEL WITH A SUCTION MACHINE BUT WERE UNSUCCESSFUL, THEY TOOK HIM TO THE HOSPITAL WHERE HIS HEALTH DETERIORATED, AND HE DIED ON (B)(6) 2024. MEDICAL CAUSES OF DEATH: HYPOXIC BRAIN INJURY, CHOKING, AND INHALATION OF ADHESIVE GEL. DURING THE AUTOPSY THERE WAS EVIDENCE OF UPPER AIRWAY OBSTRUCTION, THICK ADHESIVE GEL WAS SEEN INSIDE THE MOUTH AND PHARYNX, AND A COMPLETELY BLOCKED THE LARYNX AND TRACHEA THAT EXTENDED TO THE LEFT BRONCHUS. THE PRODUCT WAS USED ON A DAILY BASIS TO SECURE UPPER AND LOWER DENTURES. ADDITIONAL PRODUCT USAGE DETAIL WERE NOT PROVIDED AND IT WAS UNKNOWN IF THE EXACT PRODUCT WAS USED PREVIOUSLY. CONCOMITANT PRODUCT(S): NONE REPORTED. THE EVENT AND CASE OUTCOMES WERE FATAL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940556 FIXODENT ADHESIVE CREAM, VERSION UNKNOWN ADHESIVE, DENTURE - KOO KOO

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Other| D